Senior Engineer II, Injectable Drug Product Development

This is what you will do:

The primary responsibility of this position will be to support drug product technology transfers within the biologics therapeutic pipeline for Alexion, Rare Disease Business Unit of Astra Zeneca.  Transfer activities will be in support of CMC development of early phase, late phase, and commercialization of biologics therapeutics.  The Senior Engineer is generally considered as a technical subject matter expert (SME) to support all aspects of technical transfer, GMP manufacture, and process validation in collaboration with Process Development and Clinical Supply (PDCS), non-GMP internal Pilot network, Alexion Operations, Quality (QA), Regulatory (RA), Analytical Development Quality Control (ADQC) and internal and external Manufacturing sites.  

The Senior Engineer will serve as a technical lead and be responsible for assuring planning and completion of all technical documents for knowledge transfer, supporting manufacturing, and process validation activities (batch records, operating procedures, technical transfer and process validation master plans and associated protocols and reports).  The Senior Engineer will monitor, track, and trend process performance and process validation execution and data and manage timely risk identification, communication, and resolution. The successful candidate will also routinely work with Process Development, manufacturing, and other stakeholders to resolve manufacturing issues and recommend corrective actions or process improvements. This work will include direct interaction with internal and external manufacturing partners.  The Senior Engineer will also support continuous improvement for efficiency of technology transfer plans and work processes.

You will be responsible for:

• Lead technology transfer and/or process validation of drug product (DP) manufacturing processes to internal and external GMP manufacturing network for Alexion’s biologics pipeline, covering early phase, late phase, and process validation.
• Lead the development, implementation and execution of technology transfer and process validation master plans and ssupport the transition of technical leadership for validated processes to Alexion Operations.
• Lead efforts to assess readiness for early and/or late phase transfers using appropriate tools and manage risk communication with leadership to communicate proposed mitigation/s.
• Lead creation and/or technical review of batch records, process validation protocols, change controls, and deviations to support GMP manufacturing throughout lifecycle of biologics pipeline in partnering with QA and Alexion Operations as applicable.
• Lead sample coordination and planning for manufacturing campaigns, responsible for communicating sample plans to manufacturing sites, and collaborate with internal and external partners for effective sample management
• Ensure technical transfers are executed appropriately in terms of equipment, materials and evaluate impact on manufacturing process due to changes in equipment, scale, and raw materials. 
• Monitor and trend process performance and provide manufacturing floor technical support for troubleshooting and general technical oversight of ongoing manufacturing campaigns. Lead the technical decision making during initial manufacturing campaigns and interface with manufacturing site, Process Development, QA, and other relevant stakeholders to ensure tactical objectives are met.
• Ensure the compilation of data for regulatory source documents. Review IND/IMPD, BLA/MAA and other technical documents for regulatory agency submissions.  Serve as a subject matter expert on technology transfer and process validation during regulatory agency inspections.
• Ensures open communication and effective collaboration of all involved functions and external partners.
• Lead frequent technical discussions within and between functional areas through informal and formal presentations
• Support continuous improvement of efficiency of technology transfer plans and work processes
•  This role includes domestic and international travel to manufacturing sites (~up to ~25%).

You will need to have:

• A degree in related Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Biochemical, Mechanical) field.  A PhD, or a MS with at least 5 years of experience in the biotechnology/pharmaceutical industry, or a BS with at least 8 years of experience.
• Experience and in-depth technical and operational knowledge of multiple drug product unit operations (i.e., dilution, mixing, filling, CCI, and Visual Inspection).
• Understanding of GMP requirements for clinical or commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure manufacturing operations are GMP compliant.
• This role is primarily office based.  Passport and ability to travel domestically and internationally up to two weeks at a time for manufacturing site support. During travel for manufacturing support, this role requires physical capabilities to gown and degown PPE in GMP cleanroom environment and be present during manufacturing operations in a technical support role. Physical elements include standing, climbing stairs, ladders, visual capability to read manufacturing control screens, use a computer, engage in communications via phone, video, and electronic messaging.  Intellectual capabilities include engaging in problem solving and non-linear thought, analysis, and dialogue, collaboration with other peer functional representatives.
• Ability to drive for results independently and adapt to rapidly changing priorities.
• Effective problem solving and technical decision-making skills in a manufacturing environment.
• Strong oral and written communication skills and attention to detail; ability to present and defend technical and scientific approaches and decisions in both written and verbal form to internal and external partners.
• Strong collaboration skills, with ability to participate in global cross-functional teams and work effectively in a highly matrix team environment.

We would prefer for you to have:

• Knowledge and expertise in late phase manufacturing and process validation 
• Prior experience in collaborating with contract manufacturing companies
• Experience with supporting regulatory submissions and regulatory agency inspections
• Proven track record of supporting or leading continuous improvement initiatives
• Knowledge and use of basic statistical analysis methods
• Ability to influence others without direct authority and communicate with all levels of the organization.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.